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Effect of Enhanced Recovery After Surgery (ERAS) on C-reactive and Visceral Proteins (ERASAG)

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ERAS protocols
ERAS protocols
ERAS protocols
ERAS protocols
ERAS protocols
ERAS protocols
ERAS protocols
ERAS protocols
ERAS protocols
ERAS protocols
ERAS protocols
conventional pathway group
conventional pathway group
conventional pathway group
conventional pathway group
conventional pathway group
conventional pathway group
Sponsored by
The First Hospital of Jilin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Enhanced recovery after surgery, laparoscopic gastrectomy, advanced gastric cancer, C-reactive,visceral proteins

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18-75 years old
  2. Diagnosis confirmed by the endoscopic biopsy and total-body CT scan
  3. No history of the chronic renal disease ,chronic liver disease, cardiopulmonary dysfunction, ASA score≦3
  4. No neoadjuvant chemotherapy and radiotherapy
  5. No digestive obstruction and distant metastasis

Exclusion Criteria:

  1. Conversion to open gastrectomy
  2. A large amount of bleeding leading(>500ml)
  3. Patients withdrew their consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    ERAS group

    conventional pathway group

    Arm Description

    ERAS protocols

    using conventional pathway

    Outcomes

    Primary Outcome Measures

    Compartition of postoperative hospital stay

    Secondary Outcome Measures

    Change from baseline in C-Reactive Protein( CRP) and visceral proteins level
    1day before and 1-5days after operation

    Full Information

    First Posted
    January 17, 2015
    Last Updated
    January 27, 2015
    Sponsor
    The First Hospital of Jilin University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02348229
    Brief Title
    Effect of Enhanced Recovery After Surgery (ERAS) on C-reactive and Visceral Proteins
    Acronym
    ERASAG
    Official Title
    Effect of Enhanced Recovery After Surgery (ERAS) on C-reactive and Visceral Proteins in Patients With Advanced Gastric Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2013 (undefined)
    Primary Completion Date
    September 2014 (Actual)
    Study Completion Date
    October 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The First Hospital of Jilin University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The investigators designed a prospective randomized, controlled clinical trial then recruited 149 consecutive advanced gastric cancer patients. Further divided into a ERAS group (n=73) and a conventional pathway group (n=76). Surgical technique in both groups was same laparoscopic-assisted gastrectomy with D2 lymphadenectomy. Compared outcomes included clinical parameters and serum indicators.
    Detailed Description
    Enhanced recovery after surgery combined with laparoscopic-assisted gastrectomy was successfully carried out in this study. Recovery parameters such as the length of time to return to normal diet,mean hospital stay (d) were recorded.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastric Cancer
    Keywords
    Enhanced recovery after surgery, laparoscopic gastrectomy, advanced gastric cancer, C-reactive,visceral proteins

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    149 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ERAS group
    Arm Type
    Experimental
    Arm Description
    ERAS protocols
    Arm Title
    conventional pathway group
    Arm Type
    Other
    Arm Description
    using conventional pathway
    Intervention Type
    Procedure
    Intervention Name(s)
    ERAS protocols
    Intervention Description
    Normal meal allowed until 6 h before surgery and Carbohydrate drink until 2 h before surgery
    Intervention Type
    Procedure
    Intervention Name(s)
    ERAS protocols
    Intervention Description
    No bowel preparation
    Intervention Type
    Procedure
    Intervention Name(s)
    ERAS protocols
    Intervention Description
    No nasogastric placement; if used, remove on the 1st postoperative day
    Intervention Type
    Procedure
    Intervention Name(s)
    ERAS protocols
    Intervention Description
    Vasoactive drugs used if need be
    Intervention Type
    Procedure
    Intervention Name(s)
    ERAS protocols
    Intervention Description
    Temperature management
    Intervention Type
    Procedure
    Intervention Name(s)
    ERAS protocols
    Intervention Description
    Intra-abdominal drains not to be used
    Intervention Type
    Procedure
    Intervention Name(s)
    ERAS protocols
    Intervention Description
    Intraperitoneal Ropivicaine infusion
    Intervention Type
    Procedure
    Intervention Name(s)
    ERAS protocols
    Intervention Description
    On the 1st postoperative day Nasogastric catheter removed /Urinary catheter removed. Oral non-opioid analgesia/Drinking 0.5L liquid. Active mobilisation
    Intervention Type
    Procedure
    Intervention Name(s)
    ERAS protocols
    Intervention Description
    On the 2nd postoperative day：Drains removed Oral diet was initiated
    Intervention Type
    Procedure
    Intervention Name(s)
    ERAS protocols
    Intervention Description
    3-4th postoperative day： Stop oral non opioid analgesia
    Intervention Type
    Procedure
    Intervention Name(s)
    ERAS protocols
    Intervention Description
    On the5-6th postoperative day Check discharge criteria
    Intervention Type
    Procedure
    Intervention Name(s)
    conventional pathway group
    Intervention Description
    No solid foods at dinner before surgery and no liquids 12 h before surgery. Routine bowel preparation Nasogastric placement on the morning of surgery
    Intervention Type
    Procedure
    Intervention Name(s)
    conventional pathway group
    Intervention Description
    Routine use of anesthesia medicine. Standard 5-trocar laparoscopy-assisted procedure. I.V. fluids not restricted (Ringer's lactate 20 ml/kg in the first hour, then at the rate of 10-12 ml/kg/h) Routine use of abdominal drainage tubes and placement of catheters.
    Intervention Type
    Procedure
    Intervention Name(s)
    conventional pathway group
    Intervention Description
    1st postoperative day: Keep Nasogastric catheter Removal of urinary catheter Opioid analgesic by intramuscular injection Parenteral nutrition until flatus. I.V. fluids not restricted Mobilization in bed
    Intervention Type
    Procedure
    Intervention Name(s)
    conventional pathway group
    Intervention Description
    2nd postoperative day Patient is advised to get out of bed until 24-48h after surgery
    Intervention Type
    Procedure
    Intervention Name(s)
    conventional pathway group
    Intervention Description
    3-4th postoperative day： Remove nasogastric tube after flatus Oral liquids started. Encouraged to walk in the ward.
    Intervention Type
    Procedure
    Intervention Name(s)
    conventional pathway group
    Intervention Description
    5-6th postoperative day：Oral diet was changed from liquids to semi-fluids and normal food. Drains removed
    Primary Outcome Measure Information:
    Title
    Compartition of postoperative hospital stay
    Time Frame
    up to 30 days after the operation
    Secondary Outcome Measure Information:
    Title
    Change from baseline in C-Reactive Protein( CRP) and visceral proteins level
    Description
    1day before and 1-5days after operation
    Time Frame
    baseline and 5 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18-75 years old Diagnosis confirmed by the endoscopic biopsy and total-body CT scan No history of the chronic renal disease ,chronic liver disease, cardiopulmonary dysfunction, ASA score≦3 No neoadjuvant chemotherapy and radiotherapy No digestive obstruction and distant metastasis Exclusion Criteria: Conversion to open gastrectomy A large amount of bleeding leading(>500ml) Patients withdrew their consent
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Quan Wang, Doctor
    Organizational Affiliation
    The First Hospital of Jilin University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27875094
    Citation
    Mingjie X, Luyao Z, Ze T, YinQuan Z, Quan W. Laparoscopic Radical Gastrectomy for Resectable Advanced Gastric Cancer Within Enhanced Recovery Programs: A Prospective Randomized Controlled Trial. J Laparoendosc Adv Surg Tech A. 2017 Sep;27(9):959-964. doi: 10.1089/lap.2016.0057. Epub 2016 Nov 22.
    Results Reference
    derived

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    Effect of Enhanced Recovery After Surgery (ERAS) on C-reactive and Visceral Proteins

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